Performance specifications in SKUP evaluations

Analytical performance specifications

The analytical performance specifications (APSs) in the evaluations are determined by SKUP. The APSs are predominantly based on international and/or national guidelines as well as scientific publications. The APSs in SKUP evaluations are presented in the protocol and the report. These are SKUPs APSs, and represents what we consider represent state-of-the-art in point of care testing as well as clinically relevant limits.  

SKUP reviews the APSs prior to each evaluation and adjusts them if needed, based on above mentioned sources. Previously used APSs can be found in published reports, where they are referred to as analytical quality goals.

User-friendliness  

The user-friendliness is assessed by a structured questionnaire concerning all aspects of the measuring system. The questionnaire covers rating of the ease of operation, the information in the user guide/insert /quick guide, and the internal analytical quality control and test stability. For each question, the evaluator can choose the response satisfactory, intermediate or unsatisfactory. To achieve the overall rating “satisfactory”, the measuring system must reach the total rating of “satisfactory” in all subareas.